MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9732719

Device Problems Temperature Problem (3022); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Udi not available for this system.No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported that the system was unable to take 3d spins.The system had a noticeable burning smell from the image acquisition system (ias).Upon looking at the ias batteries, it was noted that the batteries showed cracking and bulging.There was no patient present when this issue was identified.

Manufacturer Narrative

The battery charger 1, battery charger 2, and motion battery charger were returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.No failure was found with the returned components while under testing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The battery charger 1, battery charger 2, and motion battery charger have been received by the manufacturer.However, analysis has not been completed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8701421
• MDR Text Key: 155044661
• Report Number: 1723170-2019-03353
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 08/02/2019
• Supplement Dates FDA Received: 07/18/2019; 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1